—#184917

Product

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

FDA product code: JOH — Tube Tracheostomy And Tube Cuff
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K944178
Affected lot / code info: Lot Number 3991195

Why it was recalled

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Root cause (FDA determination)

Packaging process control

Action the firm took

The firm initiated the recall by letter on 12/15/2020. The letter requested the following: "INSTRUCTIONS TO CUSTOMERS AND DISTRIBUTORS: 1. Locate affected product in your possession by referring to the Affected Devices List (Table 1) listed on this Recall Notice. 2. Determine the number of affected devices in your possession and complete the Response Form (Attachment 1) within 10 days of receipt, returning it to fieldactions@smiths-medical.com. The form must be returned even if you do not have any affected Bivona Cuffless FlexTend Tracheostomy Tube Devices in your possession. 3. All affected product must be returned to Smiths Medical for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. When returning product please include a copy of the Response Form (Attachment 1) inside EACH BOX. 4. Product credit will be processed once the impacted product and Response Form (Attachment 1) has been received and processed. 5. DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall with the editable Response Form for your customers (Attachment 1a) to respond appropriately."

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: US nationwide distribution.

Timeline

Recall initiated: 2020-12-15
Terminated: 2022-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.